AzTrials
AzTrials

Bone Density IncreasedPhase 2NCT06522321

Radiographic Assessment of Bone Dimension Around Immediate Implants With FDBA and I-PRF vs FDBA Alone

A Phase 2 study testing i-PRF and FDBA in people with Bone Density Increased, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The present study is a human, prospective, parallel, randomised controlled clinical trial conducted for radiographic assessment of bone dimension around immediate implants with FDBA and I-PRF vs FDBA Alone The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Bone Density Increased
What is being tested?
i-PRF and FDBA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteIndia
Study dates
15 Jul 2023to 25 Oct 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients between 18-55 years of age.
  • Presence of non-restorable single rooted teeth (maxillary or mandibular) due to trauma, caries, root resorption, root fracture, endodontic or periodontal failure.
  • Grade I or Grade II extraction socket according to El Chaar et al 2016.
  • Good oral hygiene.
  • Good patient compliance.

Who cannot join

  • Systemic complications (uncontrolled diabetes and severe cardiovascular or infectious diseases).
  • Intravenous and oral bisphosphonate therapy.
  • Patients who are psychologically unable to participate.
  • Pregnant patients, patients with bone diseases and patients on chemotherapy or radiotherapy, alcohol or drug abuse.
  • Patients with hemorrhagic disorders.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Dr. Prabhuji MLV

    Bengaluru, Karnataka, 562157

Other trials in India

About this study

Official title: Radiographic Assessment of Bone Dimension Around Immediate Implants With FDBA and I-PRF vs FDBA Alone- A Randomized Clinical Controlled Trial

The present study is a human, prospective, parallel, randomised controlled clinical trial conducted for radiographic assessment of bone dimension around immediate implants with FDBA and I-PRF vs FDBA Alone The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Read the detailed description

Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. All the patients were treated with immediate implants in endodontically and periodontically compromised sites. FDBA graft along with I-PRF is combined to form a sticky bone, this stable element is placed around the implants where bone is compromised.

The clinical and radiographic parameters were recorded at baseline, three months and six months postoperatively

Being tested
i-PRF and FDBA
Keywords
Injectable platelet rich fibrin, bone dimensions, freeze dried bone allograft
Medical subject headings
Osteosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • i-PRF and FDBABiological

    Also called platelet rich fibrin and freeze dried bone

    A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with FDBA and I-PRF (experimental group) will be placed according to the standard protocol.

    An immediate implant with FDBA( comparative group) will be placed according to the standard protocol .

    The surgical wound closure will be coapted with sutures

Study groups in NCT06522321
Study groupRoleWhat they receive
Radiographic Assessment of Bone Dimension Around Immediate with FDBA and i-PRF vs FDBAExperimentalTEST GROUP: FDBA and I-PRF with immediate implant placement. Local anesthesia is given. Atraumatic extraction is done. I-PRF is prepared by centrifugation procedure. Osteotomy is done at the selected site after radiographic assessment. Immediate implant is placement along with I-PRF and FDBA. Suture is placed at the surgical site.
Receives: Biological: i-PRF and FDBA
Radiographic Assessment of Bone Dimensions Around Immediate Implants With FDBA and I-PRF vs FDBAExperimentalCONTROL GROUP: FDBA alone with immediate implant placement. Local anesthesia is given. Atraumatic extraction is done.Osteotomy is done at the selected site after radiographic assessment. Immediate implant is placement along with FDBA alone. Suture is placed at the surgical site.
Receives: Biological: i-PRF and FDBA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone fill

    Standard digital radiographs were taken at baseline, 3 months and 6 months by paralleling/long-cone technique. Radiographic images at all the time intervals were taken by using a metallic counting grid (IOPA film grid® , BlueDent, Chennai, India). The bone-fill was measured in square millimeters by point-counting the number of squares over newly developing radiopacities at different follow up periods. Squares that were half filled or unclear were not counted.

    Measured: At baseline, 3 months and 6 months

  2. Bone dimensions

    The sites will be assessed vertically and horizontally by CBCT images taken at baseline and 6 months after the implant placement.

    Measured: At baseline, 3 months and 6 months

  3. Bone density

    Bone mineral density is obtained by the CBCT (GENORAY (PAPAYA 3D premium operation software)

    Measured: At baseline, 3 months and 6 months

  4. Marginal bone level

    distance between reference point(the implant shoulder) and the first marginal bone-to-implant contact level using standard digital radiographs

    Measured: At baseline, 3 months and 6 months

  5. Early wound healing index

    SCORE 1: COMPLETE FLAP CLOSURE NO FIBRIN LINE IN THE INTERPROXIMAL AREA SCORE 2: COMPLETE FLAP CLOSURE FINE FIBRIN LINE IN THEINTERPROXIMAL AREA SCORE 3: COMPLETE FLAP CLOSURE FIBRIN CLOT IN THE INTERPROXIMAL AREA SCORE 4:INCOMPLETE FLAP CLOSURE PARTIAL NECROSIS OF THE INTERPROXIMAL AREA SCORE 5: INCOMPLETE FLAP CLOSURE COMPLETE NECROSIS OF THE INTERPROXIMAL AREA. SCORE 1: COMPLETE FLAP CLOSURE NO FIBRIN LINE IN THE INTERPROXIMAL AREA SCORE 2: COMPLETE FLAP CLOSURE FINE FIBRIN LINE IN THEINTERPROXIMAL AREA SCORE 3: COMPLETE FLAP CLOSURE FIBRIN CLOT IN THE INTERPROXIMAL AREA SCORE 4:INCOMPLETE FLAP CLOSURE PARTIAL NECROSIS OF THE INTERPROXIMAL AREA SCORE 5: INCOMPLETE FLAP CLOSURE COMPLETE NECROSIS OF THE INTERPROXIMAL AREA. Wachet et al wound healing index will be used for obtaining the healing index

    Measured: At baseline, 3 months and 6 months

Secondary outcomes (2)

  1. GINGIVAL INDEX

    The severity of gingivitis is scored on the mesiofacial and distofacial papillae, facial and lingual margin of selected teeth.

    A blunt instrument is used to assess the bleeding potential of tissues

    The index relies entirely on visual criteria of gingivitis and eliminates the use of probing or pressure to establish the presence or absence of bleeding.

    Measured: 3 months and 6 months

  2. GINIVAL BLEEDING INDEX

    The gingival bleeding index of Ainamo J and Bay I was developed as an easy and suitable way for assessing a patient's progress in Plaque control. The presence or absence of gingival bleeding is determined by gentle probing of the gingival crevice with a periodontal probe. The appearance of bleeding within 10 seconds indicates a positive score, which is expressed as percentage of the total number of gingival margin examined.

    Measured: 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2024
  2. Study start15 Jul 2023
  3. Primary completion25 Aug 2024 (estimated)
  4. Study completion25 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Purposive Sampling technique will be done. All the patients who meet the eligibility criteria will be screened and then 20 patients will be randomly allotted into either of the two groups. The treatment allocation to the test and control group will be assigned by means of a sealed envelope containing a code derived from a computer-generated randomized list to receive either - 1. TEST GROUP (n =10)- FDBA and PRF(i-prf) with immediate implant placement. 2. CONTROL GROUP (n = 10) - FDBA alone with immediate implant placement.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06522321
Sponsor's protocol ID
02_D012_147480
Status last verified
Jul 2024
First submitted
22 Jul 2024
Last updated
30 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing i-PRF and FDBA in people with Bone Density Increased, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone fill (time frame: At baseline, 3 months and 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06522321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in